Senior Microbiology Technician

Integra LifeSciences Corporation; Braintree, Northern (MA, KY); Hybrid; USD 41,000 - 56,000; Full time

Job summary

Integra LifeSciences Corporation in Massachusetts is seeking a Senior Microbiology Technician to advance microbiological testing within the QC Microbiology team. You will perform advanced analyses, help ensure data integrity, and support investigations and CAPAs while mentoring junior staff.

You will lead environmental monitoring in cleanrooms, validate methods, review data, and contribute to regulatory compliance with FDA and ISO standards in a fast-paced medical device environment.

Qualifications

• Bachelor’s degree in Microbiology, Biology, or a related field.
• 4–7 years of experience in a cGMP-regulated environment (medical device, pharmaceutical, or related).
• Strong knowledge of microbiological testing methods and aseptic technique.
• Experience with environmental monitoring and cleanroom operations (ISO Class 7/8 preferred).
• Familiarity with FDA regulations and ISO quality standards.
• Experience with method validation and investigation processes.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Perform advanced microbiological testing including bioburden, endotoxin, growth promotion, TOC, conductivity, and utility testing.
• Conduct environmental monitoring of cleanrooms (viable and non-viable samples).
• Perform product testing of raw materials, in-process samples, and finished goods.
• Review and analyze microbiological data for accuracy and completeness; generate reports.
• Lead or support OOS investigations and CAPAs; assist root cause analysis.
• Support microbiological method validations and qualifications; SOP development.
• Train and mentor junior staff on testing methods and compliance.
• Ensure compliance with FDA, ISO 13485, and GMP requirements; assist audits.
• Maintain calibration/maintenance of lab equipment and manage sample intake.
• Coordinate sample management and send-outs to external labs.

Skills

Microbiology testing

Aseptic technique

GMP

ISO 13485

Environmental monitoring

Data analysis

Investigations

CAPA processes

Documentation

Laboratory teamwork

Education

Bachelor’s degree in Microbiology

Tools

Laboratory data systems

MS Office

Job description

## Senior Microbiology TechnicianApply: US-MA-Braintree-220-Facility: Full time: Posted Yesterday: JR-6218Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.The **Senior Microbiology Technician** serves as an advanced technical resource within the Quality Control Microbiology team. This role performs complex microbiological testing, supports investigations and validations, and provides day-to-day guidance to junior technicians. The position acts as a bridge between routine laboratory execution and leadership functions by ensuring data integrity, supporting process improvements, and assisting with compliance activities.**ESSENTIAL DUTIES AND RESPONSIBILITIES:****Technical Execution & Testing*** Perform advanced microbiological testing including: + Bioburden, Endotoxin, Growth Promotion + TOC, Conductivity, and Utility testing (e.g., Water, Compressed Air)* Conduct Environmental Monitoring of cleanrooms (viable and non-viable samples)* Perform product testing of Raw Materials, In-Process samples, and Finished Goods* Ensure proper aseptic technique and adherence to GMP/GLP standards and regulations**Data Analysis & Trending*** Review and analyze microbiological data for accuracy and completeness* Support trending of environmental monitoring and test results* Identify potential adverse trends and escalate appropriately* Generate reports and assist in presenting findings to management**Investigations & Quality Support*** Lead or support: + Out-of-Specification (OOS) investigations + Non-conformances and CAPAs* Perform root cause analysis and recommend corrective/preventive actions* Collaborate cross-functionally (QA, Manufacturing, Engineering) to resolve quality issues**Validation & Continuous Improvement*** Support microbiological method validations and qualifications (e.g., EMPQ, utilities)* Assist with implementation of new methods, systems, and process improvements* Contribute to SOP development, revisions, and continuous improvement initiatives**Training & Mentorship*** Train and mentor junior staff on: + Testing methods + Aseptic technique + SOPs and compliance requirements* Provide day-to-day technical guidance and troubleshooting support in the lab**Compliance & Audit Readiness*** Ensure compliance with FDA, ISO 13485, and other regulatory standards* Assist in preparation for and participation in: + FDA inspections + Internal and external audits* Maintain accurate and timely documentation in accordance with GMP requirements**Laboratory Operations*** Monitor laboratory equipment and ensure proper calibration and maintenance* Maintain inventory of materials, reagents, and supplies* Ensure laboratory cleanliness and adherence to safety standards* Coordinate sample management, including send-outs to external laboratories**Additional Responsibilities*** Assist in special projects and departmental initiatives* Support KPI tracking and reporting* Perform other duties as assigned**DESIRED MINIMUM QUALIFICATIONS:****Education & Experience*** Bachelor’s degree in Microbiology, Biology, or a related scientific field* **4–7 years** of experience in a cGMP-regulated environment (medical device, pharmaceutical, or related industry)**Technical Skills*** Strong knowledge of microbiological testing methods and aseptic techniques* Experience with environmental monitoring and cleanroom operations (ISO Class 7/8 preferred)* Familiarity with FDA regulations and ISO quality standards* Experience with method validation and investigation processes**Competency*** Strong analytical and problem-solving skills* Ability to recognize deviations and recommend effective corrective actions* Excellent organizational and time management abilities* Effective written and verbal communication skills* Ability to work independently and collaboratively across teams* Proficiency with Microsoft Office and laboratory data systems**Behavioral & Professional Expectations*** **Effective communication:** Clearly conveys technical information verbally and in writing; escalates issues appropriately and collaborates cross-functionally* **Prioritization & time management:** Effectively manages multiple tasks, organizes workload, and consistently meets deadlines in a fast-paced QC environment* **Adaptability:** Demonstrates flexibility and maintains performance when priorities shift or urgent issues arise (e.g., EM excursions, investigations)* **Attention to detail:** Ensures high accuracy in documentation, data review, and execution of test methods* **Problem-solving mindset:** Proactively identifies issues, proposes solutions, and supports continuous improvement initiatives* **Accountability & ownership:** Takes responsibility for assigned work, follows through on commitments, and ensures compliance with GMP standards* **Team collaboration:** Works effectively within the lab and with cross-functional teams; supports a positive, quality-focused culture* **Mentorship & support:** Provides guidance to junior staff, reinforces best practices, and supports training and knowledge sharingSalary Pay Range:$29.86 - $40.91 USD Hourly